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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02306330
Other study ID # 09HN
Secondary ID
Status Completed
Phase N/A
First received December 1, 2014
Last updated November 13, 2016
Start date December 2014
Est. completion date January 2016

Study information

Verified date December 2014
Source Oxford University Clinical Research Unit, Vietnam
Contact n/a
Is FDA regulated No
Health authority Vietnam: Ministry of HealthVietnam: Ho Chi Minh City Health Service
Study type Interventional

Clinical Trial Summary

MALDI-TOF MS is capable of directly identifying bacteria and fungi in positive blood cultures, which may be beneficial to patient management. Therefore, MALDI-TOF MS is an important new technology that is becoming routine in developed countries. It is currently unknown whether MALDITOF MS improves diagnostics, costs and patient outcomes in developing countries. This study will assess the clinical impact of a MALDITOF MS system (Maldi Biotyper, Bruker, Germany) in the resource constrained setting of Vietnam and at what cost.


Description:

When an eligible specimen from a patient shows pathogen growth, the pathogen identification will be randomized to either MaldiTof or routine diagnostics ('diagnostic pipelines'). Randomization to MaldiTof or routine diagnostics will be 1:1 with stratification by hospital and specimen type (blood vs. other). Isolates grown from all eligible specimens of the same patient will be assigned to the same diagnostic pipeline as the first randomized specimen of that patient.

Allocation to diagnostic arm will be assigned by a web based randomization program. When a pathogen is isolated from a positive eligible specimen, the laboratory technician will log onto the secure randomization program and enter the patient and specimen code. The random diagnostic pipeline allocation will then be generated, informed to the laboratory technician and logged in the study database. In the case of multiple specimens with pathogen growth for a single patient, the unique patient code will trigger the randomization program to generate the same diagnostic arm allocation as the previous sample(s).


Recruitment information / eligibility

Status Completed
Enrollment 802
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria: Pathogen isolates from the following specimens: blood or diagnostic aspirates from normally sterile sites (including cerebrospinal fluid (CSF), deep abscesses, joint fluid, peritoneal fluid, and pleural fluid, deep tissue biopsies).

Exclusion Criteria:

- Specimens negative for all pathogens

- Specimens from sputum, respiratory or non-surgical wound swabs, nails, mucosal or skin biopsies, urine, fluid from drains, skin swabs and any others not listed in the inclusion criteria.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic


Intervention

Device:
Malditof
Malditof MS system is applied for Malditof group for identifying pathogens. It takes 20 minutes to give the results.
Other:
Routine clinical microbiology
Pathogens will be identified by the routine clinical microbiology of the hospital.

Locations

Country Name City State
Vietnam National Hospital for Tropical Diseases Ha Noi
Vietnam Hospital for Tropical Diseases Ho CHi Minh City

Sponsors (3)

Lead Sponsor Collaborator
Oxford University Clinical Research Unit, Vietnam Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, National Hospital for Tropical Diseases, Hanoi, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Other Time from first growth of an eligible specimen to optimal antibiotic treatment. During hospital admission, estimated to be 0-48 hours No
Other Time from specimen collection of positive eligible specimen to optimal antibiotic treatment During hospital admission, estimated to be 0-48 hours No
Other The time from first recognition of isolate growth to issue of pathogen identification report Estimated 0-12 hours No
Other The time from specimen collection to issue of pathogen identification report Estimated 24-48 hours No
Other Time from first specimen collection to discharge Estimated to be 12 days No
Other Time from first pathogen identification to discharge Estimated to be 10 days No
Primary Proportion of patients on optimal antibiotic treatment Optimal antibiotic treatment is defined as an antibiotic treatment for at least 48 hours since positive culture, targeted to the identified pathogen and later found to cover the organisms antimicrobial resistance profile, while avoiding unnecessary broad spectrum antibiotics (e.g. avoid carbapenems or multiple agents where other agents or single agents would provide sufficient coverage). This study aims to determine The proportion of patients on optimal antibiotic treatment within 24 hours of positive culture (first growth of an eligible specimen). Within 24 hours of positive culture (first growth of an eligible specimen). No
Secondary The total duration of antibiotic treatment During treatment course, estimated to be 7-10 days. No
Secondary The total number of antibiotic switches During treatment course, estimated to be 7-10 days. No
Secondary Length of ICU stay During ICU admission, estimated to be 7 days No
Secondary Length of hospital stay During hospital admission, estimated to be 12 days No
Secondary Patient outcome: death, palliative discharge, survived with sequelae, recovered On or before discharge, estimated to be at 12 days No
Secondary Costs of microbiological testing On or before discharge, estimated to be at 12 days No
Secondary Treatment and hospital costs On or before discharge, estimated to be at 12 days No
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